IT MOH: Difference between revisions
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<div style="background: linear-gradient(135deg, #1a1a1a 0%, #2d2d2d 50%, #3a3a3a 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 28px; box-shadow: 0 4px 24px rgba(0,0,0,0.18);"> | <div style="background: linear-gradient(135deg, #1a1a1a 0%, #2d2d2d 50%, #3a3a3a 100%); border-radius: 12px; padding: 36px 40px; margin-bottom: 28px; box-shadow: 0 4px 24px rgba(0,0,0,0.18);"> | ||
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<td style="vertical-align: middle; padding-right: 20px; width: 96px; background: #ffffff; border-radius: 8px;"><div style="text-align: center; padding-left: 6px;">[[File:Italy_MOH_logo.png|alt=IT logo.|center|frameless|80x80px]]</div></td> | |||
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<div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Italy MOH — BD/RDM Registration</div> | <div style="font-size: 28px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 8px;">Italy MOH — BD/RDM Registration</div> | ||
<div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">Registration in the Italian Ministry of Health's Banca Dati / Repertorio Dispositivi Medici (BD/RDM) is required for medical devices placed on the Italian market under Regulation (EU) 2017/745 (MDR).</div> | <div style="color: #c4c4c4; font-size: 15px; line-height: 1.6;">Registration in the Italian Ministry of Health's Banca Dati / Repertorio Dispositivi Medici (BD/RDM) is required for medical devices placed on the Italian market under Regulation (EU) 2017/745 (MDR).</div> | ||
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<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1px; color: #718096; margin-bottom: 14px;">📎 Attachments</div> | |||
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<div style="font-size: 15px; font-weight: 700; color: #1a1a2e; margin-bottom: 4px;">IT Declaration of Conformity</div> | |||
<div style="font-size: 12px; color: #718096;">MyHealth App — </div> | |||
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<span style="background: #ebf8ff; color: #2b6cb0; font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 0.5px; padding: 4px 10px; border-radius: 20px;">Class IIa</span> | |||
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<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:2026-06-25, Declaration of Conformity MyHealth App v1.0 Page 1.png|250px|SW CE MDR Declaration of conformity, MyHealth app page 1]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 1</div></td> | |||
<td style="width: 33%; text-align: center; background: #f7fafc; border: 1px solid #e2e8f0; border-radius: 8px; padding: 8px;">[[File:2026-06-25, Declaration of Conformity MyHealth App v1.0 Page 2.png|250px|SW CE MDR Declaration of conformity, MyHealth app page 2]]<div style="font-size: 11px; color: #718096; margin-top: 6px;">Page 2</div></td> | |||
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<span style="font-size: 14px; color: #2d3748;">Download PDF version of the declaration: </span>'''[[Media:2026-06-25, Declaration of Conformity MyHealth App v1.0.pdf|IT Declaration of Conformity →]]''' | |||
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Latest revision as of 09:15, 9 July 2026
Main Page > TeltoHeart > IT MOH
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Italy MOH — BD/RDM Registration
Registration in the Italian Ministry of Health's Banca Dati / Repertorio Dispositivi Medici (BD/RDM) is required for medical devices placed on the Italian market under Regulation (EU) 2017/745 (MDR).
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Manufacturer & Medical Device
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Manufacturer
Teltonika Telemedic UAB
Ukmergės g. 120-1, Vilnius, Lithuania
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Single Registration Number (SRN)
LT-MF-000007642
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Device Name
MyHealth App
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Trade Name
MYHEALTH APP
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Manufacturer Code
MH001
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Device Type
Medical Device Software
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Classification & Applicable Regulation
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We, Teltonika Telemedic UAB, being the manufacturer of the above-mentioned medical device, declare under our sole responsibility that the device complies with the applicable requirements of Regulation (EU) 2017/745. The device has been assessed according to the applicable conformity assessment procedure and is eligible to bear the CE marking.
Registration Information
The device is registered in the Italian Ministry of Health Medical Device Database (BD/RDM):
📎 Attachments
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IT Declaration of Conformity
MyHealth App —
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Class IIa |
 Page 1 |
 Page 2 |
Download PDF version of the declaration: IT Declaration of Conformity →